Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 101 Versus 7.5 inch hip prostheses because the LDPE packaging bag adheres to the implant surface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a packaging adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 101 units of the VERSYS 7.5 INCH BEADED FC prosthesis, a semi-constrained total hip replacement device. The recall affects specific item numbers and lot numbers distributed worldwide, including the United States and numerous international markets.
The recall was initiated because the LDPE bag containing the implant adheres to the highly polished implant surface. This packaging defect may compromise the integrity of the device or its sterile barrier.
Healthcare providers and patients who have received these specific hip prostheses should contact Zimmer Biomet for further instructions on how to proceed. The affected units are identified by the specific item and lot numbers listed in the official recall notice.
The recalled product
- Product
- VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 101
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighZimmer Biomet Recalls Hip Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Biomet Recalls Versus Hip Stems Due to Packaging Residue
FDA (Devices) · 2018-03-21
- HighZimmer Biomet Recalls Versys Hip Prostheses Due to Sterile Barrier Risk
FDA (Devices) · 2018-03-07
- LowZimmer Versys Femoral Stem Recall Due to Packaging Adhesion
FDA (Devices) · 2013-11-06
- ModerateZimmer Biomet Recalls Versus 8 Inch Beaded Hip Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21